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NCT Number: NCT07572006

A Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies

The purpose of Part 1 (Dose Escalation) of the study is to assess how safe and tolerable JNJ-95804306 is and to find out the most suitable dose (recommended phase 2 dose [RP2D]) of JNJ-95804306. The purpose of Part 2 (Dose Expansion) is to further assess the safety of JNJ-95804306 and determine the anti-tumor activity alone and/or when administered in addition to standard of care (SoC) therapy at the putative RP2D(s) regimens in participants with hematological malignancies (cancer that begins in blood-forming tissue, such as the bone marrow, or in the cells of the immune system). For US sites: The purpose of Part 1 (Dose Escalation) of the study is to assess how safe and tolerable JNJ-95804306 is and to find out the most suitable dose (recommended phase 2 dose [RP2D]) of JNJ-95804306. The purpose of Part 2 (Dose Expansion) is to further assess the safety of JNJ-95804306 and determine the anti-tumor activity alone at the putative RP2D(s) regimens in participants with hematological malignancies (cancer that begins in blood-forming tissue, such as the bone marrow, or in the cells of the immune system).

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Key information

Conditions

Hematologic Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peter MacCallum Cancer Centre, Melbourne, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For Arm A:

  • Have a diagnosis of: Acute myeloid leukemia (AML) per International Consensus Classification (ICC) 2022 or myelodysplastic syndromes (MDS) per world health organization (WHO) 2022 classified as moderate high, high, or very high-risk per the molecular international prognostic scoring system (IPSSM). All participants must have relapsed or refractory disease and have exhausted or are ineligible for standard therapeutic options
  • Body weight greater than or equal to (>=) 40 kilograms (kg)
  • Eastern cooperative oncology group (ECOG) performance status of 0 to 2

For Arm B:

  • All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgement. Have a diagnosis of either: Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) meeting 2018 International workshop on chronic lymphocytic leukemia (iwCLL) National cancer institute (NCI) working group guidelines (Hallek 2018) that meet the following criteria:

a. Participants must have received at least 2 prior lines of therapy; b. Have clinically measurable disease

  • Body weight >= 40 kg
  • ECOG performance status of 0 to 2
  • Must sign an Informed consent form (ICF)
  • For US sites: Have a diagnosis of CLL/SLL that meets iwCLL, NCI Working Group Guidelines which is relapsed or refractory and requires treatment with no other approved therapies available that would be more appropriate in the investigator's judgement. a. Participants must have received at least 2 prior lines of therapy

Exclusion criteria

For Arm A:

  • Has acute promyelocytic leukemia according to world health organization (WHO) 2022 criteria or known active central nervous system (CNS) involvement of AML/MDS, unless in specific cohort (s) per study evaluation team (SET) decision
  • Need for supplemental oxygen use to maintain adequate oxygenation
  • Have evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted
  • For US sites: Has acute promyelocytic leukemia according to WHO 2022 criteria or known active CNS involvement of AML/MDS

For Arm B:

  • Need for supplemental oxygen use to maintain adequate oxygenation
  • Have evidence of uncontrolled systemic viral, bacterial, or fungal infection requiring initiation of parenteral treatment as medical intervention
  • Developed Richter's transformation or prolymphocytic leukemia
  • Known active CNS or leptomeningeal involvement of CLL/SLL/Non-Hodgkin lymphoma (NHL)

Treatment and study plan

JNJ-95804306

Drug

JNJ-95804306 will be administered orally.

AML SoC

Drug

AML SoC will be administered subcutaneously/intravenously.

CLL/SLL SoC

Drug

CLL/SLL SoC will be administered orally/ intravenously.

Primary outcomes

  1. Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)

    Time frame: Up to 28 days after first full dose of study drug

    DLT is defined as any toxicity that requires discontinuation of treatment; any toxicity resulting in dose reduction of study treatment, any toxicity resulting in a participant receiving less than (<) 2/3 of their intended dose; any grade 5 toxicity; non-hematologic toxicity (grade 3 or 4); and unacceptable hematologic toxicity.

  2. Number of Participants with Adverse Events (AEs) by Severity

    Time frame: Up to 6 years 5 months

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 6.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.

Secondary outcomes

  1. For US sites: Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)

    Time frame: Up to first 28 days after first dose of study drug

    DLT is defined as any toxicity that requires discontinuation of treatment; any toxicity resulting in dose reduction of study treatment, any toxicity resulting in a participant receiving less than (<) 2/3 of their intended dose; any grade 5 toxicity; non-hematologic toxicity (grade 3 or 4); and unacceptable hematologic toxicity.

  2. Serum Concentrations of JNJ-95804306

    Time frame: Up to approximately 6 years 5 months

    Serum samples will be analyzed to determine concentrations of JNJ-95804306.

  3. Area Under the Curve From Time of Administration until End of Dosing Interval (AUC[t]) of JNJ-95804306

    Time frame: Up to approximately 6 years 5 months

    AUC[t] is defined as the area under the plasma concentration time curve during a dosing interval at steady-state.

  4. Maximum Plasma Concentration (Cmax) of JNJ-95804306

    Time frame: Up to approximately 6 years 5 months

    Cmax is defined as the maximum serum concentration of JNJ-95804306.

  5. Minimum Plasma Concentration (Cmin) of JNJ-95804306

    Time frame: Up to approximately 6 years 5 months

    Cmin is defined as the minimum plasma concentration of JNJ-95804306.

  6. Complete Response (CR) in Participants with Acute Myeloid Leukemia (AML)

    Time frame: Up to 6 years 5 months

    Complete response (CR) is achieved when a participant with AML has a best response of CR (complete response with partial hematologic recovery [CRh] or complete response with incomplete hematologic recovery [CRi]) according to the European Leukemia Network (ELN) 2022 criteria.

  7. Overall Response (OR) in Participants with Myelodysplastic Syndrome (MDS)

    Time frame: Up to 6 years 5 months

    OR is achieved when a participant with MDS has a CR (any type, that is CRh or complete response with limited count recovery [CRL]), partial response (PR), or hematologic improvement (HI) according to the International Working Group (IWG) 2023 criteria.

  8. Complete Response (CR) in Participants with MDS

    Time frame: Up to 6 years 5 months

    CR is achieved when a participant with MDS has a best response of CR (including CRh/CRL) according to the IWG 2023 criteria.

  9. Overall Response (OR) in Participants with Chronic Lymphocytic Leukemia (CLL)

    Time frame: Up to 6 years 5 months

    OR is achieved when a participant with CLL has a CR or PR according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.

  10. Complete Response in Participants with CLL

    Time frame: Up to 6 years 5 months

    Complete response as per iwCLL response criteria will be reported.

  11. Overall Response in Participants with Non-Hodgkin Lymphoma (NHL) Subtypes Including Small Lymphocytic Lymphoma (SLL)

    Time frame: Up to 6 years 5 months

    Overall response is achieved when a participant with NHL subtypes including SLL has a CR or PR according to the revised response criteria for malignant lymphoma.

  12. Complete Response in Participants With NHL Subtypes Including SLL

    Time frame: Up to 6 years 5 months

    Complete response is achieved when a participant with NHL subtypes including SLL has a best response of CR according to the revised response criteria for malignant lymphoma.

  13. Overall Response in WM (Waldenstrom's Macroglobulinemia)

    Time frame: Up to 6 years 5 months

    Overall response is achieved when a participant with WM has a CR or PR according to international workshop on waldenstrom's macroglobulinemia 2013

  14. Complete Response in WM

    Time frame: Up to 6 years 5 months

    Complete response is achieved when a participant with WM has a best response of CR according to international workshop on waldenstrom's macroglobulinemia 2013.

  15. Best Overall Response (BOR) Based on Indication-Specific Criteria

    Time frame: Up to 6 years 5 months

    Participants with BOR based on indication-specific criteria will be reported.

  16. Duration of Response (DoR)

    Time frame: Up to 6 years 5 months

    DOR is defined for responders only, as time from date of initial documentation of a response to the first documented evidence of no response, disease progression, relapse, initiation of a new systemic anti-cancer therapy (besides hematopoietic stem cell transplant [HSCT]), or death, whichever comes first.

  17. Time to Response (TTR)

    Time frame: Up to 6 years 5 months

    TTR is defined for responders only, as the time from the first dose of any study treatment to first qualifying response.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Phase 1, First-in-human, Dose Escalation Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies

Important dates

Study start
2026
Primary completion
2029
Study completion
2032
First posted
May 7, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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